V.I.E – Qualification & Validation Coordinator – Life Sciences

Description du poste

As a Qualification and Validation Consultant, your expertise will support the projects of our partners whose activities are established in the production of medicines or health-related products.

You will play a central role in coordinating and executing the validation cycle with the aim of successfully completing projects within the given timelines.

To do so, you will:

• Represent the Validation department on various projects;
• Design and implement the best Validation strategy;
• Coordinate project planning with all stakeholders (Production / QA / Maintenance);
• Participate in risk assessment through the drafting of a « Risk Assessment »;
• Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS);
• Write protocols, coordinate, and ensure the proper execution of tests (URS / FAT / SAT / IQ / OQ / PQ);
• Analyze and interpret results in order to draft the corresponding reports;
• Develop training sessions and coach operators in the field; Manage deviations related to validation runs and implement the associated CAPAs.

Qualifications

• A degree in Engineering, a Master’s in Bioengineering, Industrial Pharmacy, or related fields;
• Experience in qualification and validation within a GMP environment;
• Knowledge of production processes in the pharmaceutical industry;
• The ability to work in English as well as French.
• Curious to learn more about production equipment and/or manufacturing processes;
• Organized and meticulous in drafting your GMP documentation;
• Communicative and enjoy interacting with various departments such as Production / Quality Assurance / Maintenance.

Informations supplémentaires